Locally advanced gastric cancer
Conditions
Interventions
Experimental group:The preoperative neoadjuvant chemotherapy drugs were oxaliplatin + S-1 (SOX regimen), and the preoperative treatment was 4 cycles, 3 weeks as a cycle. On the first day of each treat
Sponsors
The Second Affiliated Hospital of Air Force Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1) aged 18-75 years; 2) gastric adenocarcinoma confirmed by histopathology at the time of initial treatment; 3) According to AJCC 8th edition, the diagnosis of local progression is cT3-4AN+M0 based on preoperative endoscopic ultrasound or enhanced CT/MRI scan cTNM, and two senior general surgeons unanimously agree that it can be resected; 4) ECOG score of 0-1 and expected survival time = 3 months; 5) the damage caused by the subject's other treatment has recovered, including receiving other disease-related medication or surgery for =4 weeks, and the wound has completely healed; 6) complete imaging examination without distant metastasis; 7) no previous cancer-related treatment (including chemoradiotherapy, targeted therapy, immunotherapy, or traditional Chinese medicine); 8) have adequate organ and bone marrow function, meeting the following definitions: ? Blood routine (no blood transfusion, no use of granulocyte colony-stimulating factor (G-CSF), no use of other drugs within 14 days before treatment) ? Neutrophil count (NE) >1500/µL; Hemoglobin count (HGB) >8.0 g/dL; ? Platelet count (PLT) >100 000/µL; ? Blood Biochemistry (Liver function) ? Serum creatinine (Cr) = 2.5× upper limit of normal (ULN); ? Total bilirubin (TBIL) = 2.5×ULN; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) level =2.5×ULN 9). The patient signed the informed consent form and followed the planned visits, study treatments, laboratory tests, and other trial procedures.
Exclusion criteria
Exclusion criteria: 1) unresectable distant metastasis; 2) Her-2 and BRAF positive patients; 3) diagnosed with other malignant tumors within 5 years (repeat cancer patients); 4) previous allergy to any component of the investigational drug; 5) subjects had poor control of refractory pleural, peritoneal or pericardial effusion; 6) prior immunotherapy with anti-PD-1 or PD-L1 or CTLA-4 or Car-T; 7) History of interstitial lung disease (excluding radiation pneumonitis without corticosteroid treatment) and non-infectious pneumonia; 8) the subject has any active autoimmune disease or a history of autoimmune disease (such as the following, but not limited to: autoimmune hepatitis, interstitial pneumonia, uveitis, enteritis, hepatitis, hypophysitis, vasculitis, nephritis, hyperthyroidism, hypothyroidism; Subjects with vitiligo or complete remission of asthma in childhood without any intervention in adulthood were included. Subjects with asthma requiring medical intervention with bronchodilators were excluded). 9) The subject is receiving immunosuppressive, systemic, or absorbable topical hormone therapy for immunosuppression (prednisone at a dose of >10mg/ day or other equivalent efficacy hormone) and has continued to do so within 2 weeks before enrollment; 10) Severe infection (CTCAE > 2) occurred 4 weeks before the first dose of study drug, such as severe pneumonia requiring hospitalization, bacteremia, and infectious complications; Prophylactic antibiotics were excluded if there was active pulmonary inflammation on baseline chest imaging, signs and symptoms of infection within 2 weeks before the first dose of study drug, or the need for oral and intravenous antibiotics. 11) hypertensive patients (systolic blood pressure >140 mmHg, diastolic blood pressure >90 mmHg) with grade I or above myocardial ischemia or infarction, arrhythmia and grade II heart failure; 12) subjects had an acute cardio-cerebrovascular disease (acute cerebral infarction, acute coronary syndrome, etc.) within one month, and their cardiovascular clinical symptoms or diseases were not well controlled; Patients with NYHA class ?-? cardiac dysfunction, or left ventricular ejection fraction (LVEF) 1.5, APTT > 1.5ULN) and bleeding tendency; 15) long-term unhealed wounds or fractures; Had undergone major surgery within 4 weeks or had severe traumatic injury or fracture or ulcer; 16) subjects with congenital or acquired immunodeficiency (such as HIV infection), or active hepatitis (hepatitis B reference: HBV DNA test value exceeded the upper limit of normal; Hepatitis C reference: HCV viral titer or RNA test value exceeding the upper limit of normal); 17) patients with a history of psychotropic drug abuse and inability to abstain or with mental disorders; 18) patients with concomitant diseases that, according to the investigator's judgment, seriously endanger patient safety or prevent patients from completing the study; 19) patients who were deemed unsuitable for inclusion by the investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Major pathological response rate (MPR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Pathological complete response rate;R0 resection rate;Objective Response Rate (ORR);Quality of life; | — |
Countries
China
Contacts
Public ContactXianli He
The Second Affiliated Hospital of Air Force Medical University
Outcome results
None listed